BIFURCATED BALLOON CATHETERS AND METHODS OF USE
Balloon catheters for treating a diseased bifurcated blood vessel that includes a catheter hub, a proximal balloon hub, a distal balloon hub, a catheter tip, a catheter shaft comprising a proximal shaft and a distal shaft, and a bifurcated balloon assembly with a first balloon and second balloon that are substantially parallel. A proximal end of the proximal shaft is connected to the catheter hub and a distal end of the proximal shaft is connected to the proximal balloon hub. A proximal end of the distal shaft is connected to the distal balloon hub and a distal end of the distal shaft is connected the catheter tip. A proximal end of the first balloon is connected to the proximal balloon hub, a distal end of the first balloon is connected to the distal balloon hub, and a distal end of the second balloon is connected to the distal balloon hub.
This application claims priority to U.S. Provisional Application No. 63/291,190, filed on Dec. 17, 2021 and titled “BIFURCATED BALLOON CATHETERS AND METHODS OF USE,” which is hereby incorporated by reference in its entirety.
FIELDBifurcated balloon catheters and methods of using the same are described herein.
BACKGROUNDAorto-iliac occlusive disease (AIOD) refers to narrowing or stenosis of the blood vessels involving the infrarenal aorta and the two iliac arteries. In complex cases the aorto-iliac bifurcation may be involved.
Balloon angioplasty and placement of bare or covered stents are current methods of treating local narrowing or occlusions of arteries. The “kissing-balloon” technique, the “kissing-stent” technique, and the Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) technique have been developed to treat AOID involving the aorto-iliac bifurcation. These three methods include simultaneous placement of two parallel “kissing” balloons across the bifurcation. A shortcoming of these techniques is the need for accurate simultaneous placement and inflation of the two kissing balloons. Another shortcoming is that the balloons form a dual double barrel in the aorta and do not conform to the aortic wall. An additional shortcoming of the two-stenting technique is the disruption of the natural blood flow through the bifurcation that can lead to thrombus formation, hemolysis, emboli and restenosis. Another shortcoming is the technical skill set required to perform these procedures. Even further yet, another shortcoming is that the two stenting technique makes re-intervention procedures using a retrograde approach (up- and over technique) challenging.
As an alternative approach, self-expanding bifurcated stent grafts (e.g., AFX device manufactured by Endologix) have been placed to treat complex aorto-iliac disease. The advantage of the bifurcated stent graft is that it preserves the bifurcation avoiding flow disturbances and allowing for a retrograde approach for re-intervention. A shortcoming of this approach is that the self-expanding stent may have insufficient outward force to maintain flow. Another shortcoming is the large profile (cross-sectional area) of the delivery system. A third shortcoming is the exposed stent structures of the AFX device that can lead to flow disruptions, thrombus formation and difficulties with future cross-over interventions. Another shortcoming is the complex procedural steps and high technical skill set that is required to place the AFX device in a diseased aorto-iliac bifurcation. Further yet, another shortcoming is the difficulty to accurately size self-expanding stents to the variability in aortic and iliac diameters, which can lead to infolding and blood flow disturbances and/or a lack of vessel wall apposition. Other self-expanding abdominal aortic aneurysm stent grafts are sometimes used to treat aortoiliac occlusive disease, but they have similar shortcomings as the AFX system.
There is a need for medical devices and methods for the treatment of AIOD involving the aorto-iliac bifurcation that can overcome the above listed shortcomings of existing methods.
BRIEF SUMMARYDescribed herein are bifurcated balloon catheter systems and methods for the treatment of branching blood vessels. The systems can be introduced percutaneously or by surgical cutdown into a patient's arterial system. The bifurcation from the aorta to the iliac arteries (aortoiliac bifurcation) is used as an example of a branching blood vessel which can be treated with the systems described herein. It is understood that the application of the systems described herein are not limited to the aorto-iliac bifurcation. The systems and methods of use described herein can be applied to any branching or bifurcated artery, vein, or airway in a body. In some embodiments, the body is the body of a mammal. In other embodiments, the mammal is a human. The words systems, devices, medical devices, and/or apparatuses are used herein interchangeably.
For consistency, when describing the systems, the direction toward the external end of the system outside the body is referred to as “proximal” and the direction away from the external end of the system is referred to as “distal”. The side on which the system is inserted into the arteries is referred to as “ipsilateral”, the opposite side is referred to as “contralateral”. For example, if the system is inserted into an artery of the right leg, the right side of the body is referred to as ipsilateral and the right iliac artery is referred to as the ipsilateral iliac artery. The left side is referred to as contralateral and the left iliac artery is referred to as the contralateral iliac artery.
In some embodiments, the present disclosure includes a balloon catheter for the treatment of a bifurcated vessel. The balloon catheter can be used to perform an angioplasty of the diseased bifurcated vessel. The balloon catheter can be used to deploy a cylindrical or a bifurcated stent into a bifurcated vessel. The balloon catheter can be used to deploy a cylindrical or a bifurcated covered stent into a bifurcated vessel. The balloon catheter can be used to deliver a therapeutic agent to the walls of the bifurcated vessel. The balloon catheter can be used to deliver energy to the walls of the bifurcated vessel. The balloon catheter can be used to temporarily occlude the bifurcated vessel.
In some embodiments, a balloon catheter for performing an angioplasty of the aorto-iliac bifurcation or for placing a bifurcated stent into the aorto-iliac bifurcation is disclosed. The balloon catheter comprises a catheter hub, a proximal and distal balloon hub, a proximal and a distal shaft, and a bifurcated balloon assembly located between the proximal and the distal balloon hub. The balloon assembly comprises of two cylindrical balloons which are arranged substantially in parallel to each other: a first (ipsilateral) balloon that is connected on the proximal end to the proximal balloon hub and on the distal end to the distal balloon hub, and a second (contralateral) balloon that has a free proximal end and is connected on the distal end to the distal balloon hub. In some embodiments, the balloon assembly comprises an additional restraining sleeve that is placed over the distal sections of both balloons.
The balloon catheter includes a bifurcated inflation lumen that extends from the catheter hub to the distal balloon hub and has a branch from the distal balloon hub to the contralateral balloon. The bifurcated inflation lumen is connected to an inflation port within the catheter hub and is in fluid communication with the first and the second balloon. The balloon catheter can include a second bifurcated lumen that extends from the catheter hub to the distal shaft and has a branch from the distal balloon hub through the contralateral balloon shaft. The second bifurcated lumen includes a contralateral guidewire assembly having a first proximal end that exits the balloon catheter at the catheter hub and a second proximal end that exits the balloon catheter at the free proximal end of the second (contralateral) balloon, and a distal end that is housed within the distal shaft. The first proximal end of the contralateral guidewire assembly is connected to a contralateral actuator handle. The second contralateral proximal end has a flexible radiopaque guidewire tip for advancing the guidewire atraumatically through the vasculature. Rotating the contralateral actuator handle rotates the contralateral guidewire tip. Moving the contralateral actuator handle proximally moves the contralateral guidewire tip proximally and moving the contralateral actuator handle distally moves the contralateral guidewire tip distally.
The balloon catheter can include a multi-purpose lumen extending from a port in the catheter hub to the proximal balloon hub. The multi-purpose lumen can house the tip of the contralateral guidewire during device insertion. The multi-purpose lumen can provide a pathway for a tether wire that is connected at its proximal end to a tether handle and on the distal end to the free proximal end of the contralateral balloon. The multi-purpose lumen can provide a pathway for a snare to capture the tip of the contralateral guidewire. The multi-purpose lumen can provide a pathway for injecting contrast medium into the blood stream.
In other embodiments, a protective sheath can be mounted onto the balloon catheter to facilitate the passage of the balloon catheter through an introducer sheath or guide catheter. The protective sheath is inserted past the hemostasis valve of the introducer sheath or guide catheter and prevents the hemostasis valve from engaging with the balloon catheter.
In one embodiment, a balloon catheter for treating a diseased bifurcated blood vessel is described. The balloon catheter comprises a catheter hub; a proximal balloon hub; a distal balloon hub; a catheter tip; a catheter shaft comprising a proximal shaft and a distal shaft, wherein the proximal end of the proximal shaft is connected to the catheter hub and the distal end of the proximal shaft is connected to the proximal balloon hub, the proximal end of the distal shaft is connected to the distal hub and the distal end of the distal shaft is connected the catheter tip; a bifurcated balloon assembly comprising a first balloon and a second balloon, wherein the first balloon and the second balloon are arranged substantially in parallel, and wherein the proximal end of the first balloon is connected to the proximal balloon hub, the distal end of the first balloon is connected to the distal balloon hub, and the distal end of the second balloon is connected to the distal balloon hub.
In another embodiment, a method of deploying a balloon-expandable bifurcated stent into the aorto-iliac bifurcation is disclosed. The method utilizes an embodiment of the balloon catheter described above and a bifurcated balloon-expandable stent crimped onto the balloon assembly. The main body of the bifurcated stent is crimped onto the distal sections of both balloons. The first branch stent of the bifurcated stent is crimped onto the proximal section of the first balloon and the second branch stent of the bifurcated stent is crimped onto the proximal section of the second balloon. The method is comprised of the following steps:
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- a) Advancing a guidewire from an ipsilateral leg artery through the ipsilateral iliac artery into the aorta.
- b) Advancing the balloon catheter over the guidewire until the balloon assembly is distal to the aorto-iliac bifurcation.
- c) Advancing the contralateral actuator handle distally to release the tip of the contralateral guidewire from the multi-purpose lumen.
- d) Ejecting contrast medium through the multi-purpose lumen to visualize the aorto-iliac bifurcation under fluoroscopy.
- e) Advancing the contralateral actuator handle proximally to advance the contralateral guidewire tip into the contralateral iliac artery.
- f) Advancing the balloon catheter proximally to place the bifurcated stent onto the aorto-iliac bifurcation.
- g) Injecting fluid into the inflation lumen, inflating the balloon assembly, and deploying the bifurcated stent into the aorto-iliac bifurcation.
- h) Withdrawing the fluid from the inflation lumen to deflate the balloon assembly.
- i) Advancing the balloon catheter distally until the balloon assembly is distal to the aortoiliac bifurcation.
- j) Ejecting contrast medium through the multi-purpose lumen to visualize the aorto-iliac bifurcation under fluoroscopy.
- k) Retracting the contralateral guidewire into the contralateral balloon shaft.
- l) Pulling on the tether wire to place the contralateral balloon parallel to the ipsilateral balloon.
- m) Removing the balloon catheter from the patient's body.
The preceding steps do not need to occur in the order presented. Also, in some embodiments not all the steps need to be performed, e.g. steps can be removed. In other embodiments, additional steps can be performed, e.g. steps can be added.
In yet another embodiment, a method of performing a balloon angioplasty of the aortoiliac bifurcation is disclosed. The method utilizes an embodiment of the balloon catheter described above. The method is comprised of the following steps:
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- a) Advancing a guidewire from an ipsilateral leg artery through the ipsilateral iliac artery into the aorta.
- b) Advancing the balloon catheter over the guidewire until the balloon assembly is distal to the aorto-iliac bifurcation.
- c) Advancing the contralateral actuator handle distally to release the tip of the contralateral guidewire from the multi-purpose lumen.
- d) Ejecting contrast medium through the multi-purpose lumen to visualize the aorto-iliac bifurcation under fluoroscopy.
- e) Advancing the contralateral actuator handle proximally to advance the contralateral guidewire tip into the contralateral iliac artery.
- f) Advancing the balloon catheter proximally to, at least partially, place the balloon assembly into the branch vessels.
- g) Injecting fluid into the inflation lumen, inflating the balloon assembly.
- h) Withdrawing the fluid from the inflation lumen to deflate the balloon assembly.
- i) Advancing the balloon catheter distally until the balloon assembly is distal to the aortoiliac bifurcation.
- j) Ejecting contrast medium through the multi-purpose lumen to visualize the aorto-iliac bifurcation under fluoroscopy.
- k) Retracting the contralateral guidewire into the contralateral balloon shaft.
- l) Advancing a snare though the multi-purpose lumen.
- m) Capturing the contralateral guidewire tip with the snare and pulling the contralateral guidewire tip against or into the proximal balloon hub.
- n) Removing the balloon catheter from the patient's body.
The preceding steps do not need to occur in the order presented. Also, in some embodiments not all the steps need to be performed, e.g. steps can be removed. In other embodiments, additional steps can be performed, e.g. steps can be added.
In some embodiments, there can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more lumens within the balloon catheter.
For ease and clarity of disclosure, the lumens in
In some embodiments, the proximal balloon hub can comprise two proximal openings and one distal opening. In other embodiments, the proximal balloon hub can comprise at least one proximal opening and at least one distal opening. In some embodiments, the proximal balloon hub can comprise one or more proximal openings and one or more distal openings.
In some embodiments, the proximal balloon hub can comprise one proximal opening and two distal openings. In other embodiments, the proximal balloon hub can comprise at least one proximal opening and at least one distal opening. In some embodiments, the proximal balloon hub can comprise one or more proximal openings and one or more distal openings.
In some embodiments, the balloon catheter can comprise three hubs: a catheter hub located at the proximal end of the catheter and two balloon hubs located at the proximal and distal ends of the balloons. At least three lumens terminate at each of the three hubs. The first, second, third, and fourth lumen terminate at the catheter hub. The second and fourth lumen and the lumen of the first balloon terminate at the proximal balloon hub. The third, fifth, and sixth lumen and the lumen of the first balloon and the lumen of the second balloon terminate at the distal balloon hub.
In other embodiments, the balloon catheter can comprise 1, 2, 3, 4, 5, 6 or more hubs.
Besides housing the tether wire, the second lumen can serve other functions. For example, in some embodiments, the second lumen can provide a passage for advancing a snare from the catheter hub. The snare can be used as an alternative way of pulling the second balloon toward the first balloon. The second lumen can also be used for injecting contrast medium into the blood stream. In other embodiments of the balloon catheter, the multi-purpose second lumen can be replaced by more than one lumen(s) that perform the individual functions described herein.
An introducer sheath can be used to facilitate the insertion of the balloon catheter into the vasculature.
In some embodiments, a method is disclosed for placing a bifurcated stent into the aortoiliac bifurcation using an embodiment of the balloon catheter described herein.
In the next step illustrated in
In another embodiment, a method is disclosed for performing a balloon angioplasty of the aorto-iliac bifurcation using an embodiment of a balloon catheter described herein.
The preceding disclosures are illustrative embodiments. It should be appreciated by those of skill in the art, having the benefit of this disclosure, that the devices, techniques, and methods disclosed herein elucidate representative embodiments that function well in the practice of the present disclosure. However, those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments that are disclosed and still obtain a like or similar result without departing from the spirit and scope of the disclosure.
The terms “a” and “an” and “the” and similar referents used in the present disclosure (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.”
Groupings of alternative elements or embodiments in portions of this disclosure are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.
Various embodiments are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on those preferred embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects those of ordinary skill in the art to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
Specific embodiments disclosed herein may be further limited in the claims using consisting of or consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein.
Further, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.
Claims
1. A balloon catheter for treating a diseased bifurcated blood vessel, the balloon catheter comprising:
- a catheter hub;
- a proximal balloon hub;
- a distal balloon hub;
- a catheter tip;
- a catheter shaft comprising a proximal shaft and a distal shaft, wherein a proximal end of the proximal shaft is connected to the catheter hub and a distal end of the proximal shaft is connected to the proximal balloon hub, a proximal end of the distal shaft is connected to the distal balloon hub and a distal end of the distal shaft is connected the catheter tip; and
- a bifurcated balloon assembly comprising a first balloon and a second balloon, wherein the first balloon and the second balloon are arranged substantially in parallel,
- wherein a proximal end of the first balloon is connected to the proximal balloon hub, a distal end of the first balloon is connected to the distal balloon hub, and a distal end of the second balloon is connected to the distal balloon hub.
2. The balloon catheter of claim 1, further comprising a first lumen that extends from a first port of the catheter hub through the proximal shaft, the proximal balloon hub, the first balloon, the distal balloon hub, the distal shaft, and the catheter tip.
3. The balloon catheter of claim 2, further comprising a second lumen that extends from a second port of the catheter hub through the proximal shaft, and the proximal balloon hub to a distal opening in the proximal balloon hub.
4. The balloon catheter of claim 3, further comprising a third lumen that extends from a third port of the catheter hub through the proximal shaft, the proximal balloon hub, the first balloon, and the distal balloon hub to a distal opening in the distal balloon hub.
5. The balloon catheter of claim 4, further comprising a fourth lumen that extends from a fourth port of the catheter hub through the proximal shaft, the proximal balloon hub, the first balloon, the distal balloon hub, a cavity of the distal balloon hub, and into the second balloon,
- wherein a portion of the fourth lumen is formed by the proximal shaft.
6. The balloon catheter of claim 5, further comprising a fifth lumen that extends from the distal opening in the distal balloon hub through the distal balloon hub and the second balloon to a contralateral tip of the second balloon.
7. The balloon catheter of claim 6, further comprising a sixth lumen formed by the distal shaft,
- wherein the sixth lumen extends from the proximal end of the distal shaft to the catheter tip.
8. The balloon catheter of claim 7, further comprising a contralateral guidewire assembly comprising:
- a first guidewire that extends through the third lumen into the sixth lumen;
- a second guidewire that extends from the sixth lumen through the fifth lumen and proximally beyond the contralateral tip of the second balloon; and
- a connector coupled to the first guidewire and to the second guidewire, the connector is housed within the sixth lumen.
9. The balloon catheter of claim 8, wherein the second guidewire extends into the distal opening of the proximal balloon hub and the second lumen.
10. The balloon catheter of claim 8, wherein a proximal pull on a proximal end of the first guidewire proximally translates the connector and proximally translates the second guidewire.
11. The balloon catheter of claim 8, wherein a distal push on a proximal end of the first guidewire distally translates the connector and distally translates the second guidewire.
12. The balloon catheter of claim 7, further comprising a tether that extends from the second port through the second lumen and out of the distal opening of the proximal balloon hub and configured to connect to the contralateral tip of the second balloon.
13. The balloon catheter of claim 12, wherein a distal end of the tether comprises a loop snare configured to connect to the second guidewire.
14. The balloon catheter of claim 12, further comprising a loop attached at the proximal end of the first balloon, wherein the tether extends out of the second lumen through the loop and coupled to the contralateral tip of the second balloon.
15. The balloon catheter of claim 7, further comprising:
- a first tether that extends from the second port through the second lumen and out of the distal opening of the proximal balloon hub and coupled to the contralateral tip of the second balloon; and
- a second tether that extends from the second port through the second lumen and out of the distal opening of the proximal balloon hub and coupled to the contralateral tip of the second balloon,
- wherein the first tether wraps clockwise around a proximal portion of the first balloon and the second tether wraps counterclockwise around the proximal portion of the first balloon.
16. A bifurcated stent assembly for placing a bifurcated stent into a diseased bifurcated blood vessel, the bifurcated stent assembly comprising:
- a catheter hub;
- a proximal balloon hub;
- a distal balloon hub;
- a catheter tip;
- a catheter shaft comprising a proximal shaft and a distal shaft, wherein a proximal end of the proximal shaft is connected to the catheter hub and a distal end of the proximal shaft is connected to the proximal balloon hub, a proximal end of the distal shaft is connected to the distal balloon hub and a distal end of the distal shaft is connected the catheter tip;
- a bifurcated balloon assembly comprising a first balloon and a second balloon, wherein the first balloon and the second balloon are arranged substantially in parallel; and
- a bifurcated stent comprising a main body portion, first branch portion, and a second branch portion,
- wherein a proximal end of the first balloon is connected to the proximal balloon hub, a distal end of the first balloon is connected to the distal balloon hub, and a distal end of the second balloon is connected to the distal balloon hub, and
- wherein the main body portion is disposed around distal portions of the first balloon and the second balloon, the first branch portion is disposed around a proximal portion of the first balloon, and the second branch portion is disposed around a proximal portion of the second balloon.
17. The bifurcated stent assembly of claim 16, further comprising a tether that extend through a lumen of the catheter hub through the proximal shaft, and the proximal balloon hub to an distal opening of the proximal balloon hub, wherein the tether extends through the first branch portion and curves into the second branch portion and is coupled to a contralateral tip of the second balloon.
18. A method for placing a bifurcated stent into a diseased bifurcated blood vessel comprising:
- advancing a bifurcated stent assembly over a guidewire to the bifurcated blood vessel through a first vessel, the bifurcated blood vessel comprising a first vessel, a second vessel, and a third vessel, the bifurcated stent assembly comprising: a catheter hub; a proximal balloon hub; a distal balloon hub; a catheter tip; a catheter shaft comprising a proximal shaft and a distal shaft, wherein a proximal end of the proximal shaft is connected to the catheter hub and a distal end of the proximal shaft is connected to the proximal balloon hub, a proximal end of the distal shaft is connected to the distal balloon hub and a distal end of the distal shaft is connected the catheter tip; a bifurcated balloon assembly comprising a first balloon and a second balloon, wherein the first balloon and the second balloon are arranged substantially in parallel, and wherein a proximal end of the second balloon has a contralateral tip; and a bifurcated stent comprising a main body portion, first branch portion, and a second branch portion, wherein a proximal end of the first balloon is connected to the proximal balloon hub, a distal end of the first balloon is connected to the distal balloon hub, and a distal end of the second balloon is connected to the distal balloon hub, and wherein the main body portion is disposed around distal portions of the first balloon and the second balloon, the first branch portion is disposed around a proximal portion of the first balloon, and the second branch portion is disposed around a proximal portion of the second balloon;
- advancing the bifurcated stent assembly the second vessel until the contralateral tip clears the bifurcated blood vessel;
- retracting a contralateral guidewire from the proximal balloon hub, the contralateral guidewire extends from the distal shaft through the distal balloon hub, the second balloon, the contralateral tip, and the proximal balloon hub;
- extending the contralateral guidewire into the third vessel adjacent to the first vessel and the second vessel;
- advancing the second balloon and the second branch portion into the second vessel and simultaneously retracting the first balloon and the first branch portion into the first vessel, wherein the first balloon and the second balloon are not parallel;
- inflate the first balloon and the second balloon to expand the bifurcated stent against walls of the first vessel, the second vessel, and a third vessel;
- deflate the first balloon and the second balloon;
- advance the first balloon and the second balloon into the second vessel;
- pulling the second balloon against the first balloon so that the first balloon and the second balloon are substantially parallel; and
- retracting the bifurcated stent assembly from the first vessel.
19. The method of claim 18, further comprising injecting contrast medium through the proximal balloon hub into the second vessel after the contralateral tip clears the bifurcated blood vessel.
20. The method of claim 18, further comprising injecting contrast medium through the proximal balloon hub into the second vessel after the bifurcated stent is deployed.
Type: Application
Filed: Dec 16, 2022
Publication Date: Jun 22, 2023
Inventor: Stefan Georg Schreck (South Jordan, UT)
Application Number: 18/067,321